Status:
COMPLETED
Ambrosia: Evaluating the Effects of a Food-As-Medicine Platform on Gut Microbiome Composition and Metabolism
Lead Sponsor:
Persephone Biosciences
Conditions:
Impact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome Composition
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The objective of this study is to test whether dietary behavior modification impacts diet quality and stool microbiome composition and metabolism using microbial whole genome sequencing, targeted meta...
Eligibility Criteria
Inclusion
- Adults 18 to 64 years old at the time of enrollment at high risk for colorectal cancer, defined as follows:
- EITHER a personal history of colorectal cancer, advanced adenoma, or 3 or more non-advanced adenomas in a single screening
- OR TWO of the following criteria:
- One or more first-degree relatives with a history of colorectal cancer
- Body mass index above 30 (Persephone will calculate given height and weight
- Have smoked an average of 5 or more cigarettes (1/4 pack) per day for a continuous period of 10 years or more.
- Able to provide stool samples at study start and after approximately 5 months
- Willing and able to undergo virtual Medical Nutrition Therapy based on cohort assignment
- Willing to complete online questionnaires concerning diet and lifestyle, in English
- Competency in spoken and written English
- Can provide written informed consent
Exclusion
- Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C
- Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis
- A history of Crohn's Disease, Inflammatory Bowel Disease, or chronic colitis.
- Active cancer in the past 2 years, or currently undergoing any form of cancer therapy.
- Confirmed case of COVID-19 or influenza within one month prior to enrollment
- Oral or systemic antibiotic or probiotic use, or a known GI infection, within 3 months prior to enrollment
- Engaged in a nutritional or dietary intervention in the past 3 months.
- Women who are pregnant or plan to become pregnant in the next 6 months, or currently nursing.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2025
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT06091813
Start Date
November 1 2023
End Date
March 15 2025
Last Update
July 31 2025
Active Locations (1)
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1
Persephone Biosciences, Inc.
San Diego, California, United States, 92121